Bernstein Training Courses

Linking Good Science with Regulatory Expectations: Streamlining Early CMC Drug Development - Understanding and Interpreting current FDA and EU regulations and guidance documents to facilitate approval of IND and CTA IMPD submissions

GMPs for Clinical Supplies and Investigational Medicinal Products: Global Regulations, Guidelines, Practical Approaches and Best Practices

Bernstein Training Courses are 1-2 day educational programs held throughout the year at various venues and locations, or at your facility. They are focused on selected areas of CMC drug development and intended to:

• provide a "big picture" overview so that new and experienced members of staff can see how their responsibilities relate to the overall program
• provide reasons why tasks are done so that attendees can see the impact from upstream and impact on downstream activities
• merge contemporary industrial best practices with regulatory requirements
• interpret and explain current global regulations and guidance documents
• discuss the tough issues and hot topics
• answer your questions

Bernstein Training Courses are also available as customized in-house training seminars. A comprehensive list of curriculum topics and modules available for your selection is provided. These programs are specifically designed to address and meet your GMP training requirements. Some of the more common programs are:

Essential Concepts of CTM (Clinical Trial Material) for Busy Clinical Research Professionals [1 day] with David Bernstein, Ph. D.

The Clinical Supply Process: Planning, Logistics, Regulatory Requirements, Manufacturing, Packaging and Labeling of Investigational Materials with David Bernstein, Ph. D. [3-day basic and 2-day advanced versions are available]

Preparing for a QP (Qualified Person) Inspection [1 day] with David Bernstein, Ph. D.